Home NDC 43063-328 Carbamazepine
Product NDC 43063-328
11-digit product format 430630328
Labeler code 43063
Product ID 43063-328_5c189689-fae2-4526-e063-6294a90aa382
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA074649
Marketing category ANDA
Marketing start 1996-10-03
Substance CARBAMAZEPINE
Active strength 200 mg/1
Pharmacologic classes Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074649-001 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074649-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074649-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 1996-10-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Carbamazepine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMAZEPINE 200 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43063-328-12 Carbamazepine 12 in 1 BOTTLE, PLASTIC TABLET 12 16 43063-328-30 Carbamazepine 30 in 1 BOTTLE, PLASTIC TABLET 30 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Carbamazepine ACTIVE INGREDIENT 33CM23913M CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 Carbamazepine ACTIVE MOIETY 33CM23913M CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 diethyl phthalate INACTIVE INGREDIENT UF064M00AF CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-328 CARBAMAZEPINE TABLET [PD-RX PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20250109_ce5aec7a-e161-46bf-8fc0-afb41689e59a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carbamazepine CARBAMAZEPINE A-S Medication Solutions 1dc2a4d3-2ebc-4c9b-a347-92acd9f231f2 2026-06-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074649 application number: ANDA074649 Carbamazepine CARBAMAZEPINE Golden State Medical Supply, Inc. 8a1ce79d-18ea-f30b-e053-2995a90ad1fb 2026-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074649 application number: ANDA074649 Carbamazepine CARBAMAZEPINE Bryant Ranch Prepack 2d2c5317-4072-477b-a4e2-f6765fc71657 2025-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074649 application number: ANDA074649 Carbamazepine CARBAMAZEPINE Aphena Pharma Solutions - Tennessee, LLC 697f3e5a-c84b-44a6-b9f3-15e7d9bb6395 2024-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074649 application number: ANDA074649
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-328-12 43063032812 12 TABLET in 1 BOTTLE, PLASTIC (43063-328-12) 12 tablet 2009-08-11 0000-00-00 No No Current 43063-328-30 43063032830 30 TABLET in 1 BOTTLE, PLASTIC (43063-328-30) 30 tablet 2009-08-11 0000-00-00 No No Current